MAUDE Adverse Event Report: ARTHREX, INC. SUREFIRE SCORPION NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-13991N

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528); Failure to Align (2522); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/17/2014

Event Type  Injury  

Event Description

It was reported that the tip of the needle broke off during a rotator cuff repair.As the surgeon attempted to pass the scorpion needle through the cuff, needle mis-aligned with device.On the next attempt, the tip of needle broke at the notch.The surgeon performed a scope of the cuff from different port angles and could not locate the tip.He felt it was deep in the soft tissue and would encapsulate.No further issues have been reported related to this incident.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The complainant's event was caused by a broken needle point.The mating part (instrument) used in the event was not returned.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

• Brand Name: SUREFIRE SCORPION NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337017
• MDR Report Key: 3626429
• MDR Text Key: 4176010
• Report Number: 1220246-2014-00011
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: AR-13991N
• Device Lot Number: 933339Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other